510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K210573Velofix SA Cervical CageU&I Corporation20211—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203816DeGen Navigated InstrumentationDegen Medical20211—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K210472SPINEART Navigation Instrument SystemSpineart20215—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K202380Born PT-LIF Cage HASpineworxx AG20210—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K200429BEE CagesNGMedical GmbH202111—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—